Hifibio Therapeutics, a platform player until now, has secured an oversubscribed $37.5 million series B financing aimed at helping it build its own pipeline of antibody therapies for cancer and autoimmune disorders. Meanwhile, the company will continue to form new strategic partnerships, it said, such as earlier-established tie-ups with Pfizer Inc. and Janssen Biotech Inc.
Armed with a patented version of a drug first approved in 1973 for a much different use, Soleno Therapeutics Inc. has initiated a phase III trial aimed at addressing one of the chief symptoms of Prader-Willi syndrome (PWS): insatiable hunger, or hyperphagia. The Redwood City, Calif.-based company, formed last year after Capnia Inc. acquired Essentialis Inc., has already scored both U.S. and EU orphan status for the drug, a controlled-release formulation of diazoxide choline. Now, with its trial kicking off at Seattle Children's Hospital, it's getting closer to potentially addressing a large portion of the 300,000 to 400,000 individuals worldwide with the rare genetic condition.
High prescription drug prices took center stage in Washington Friday as President Trump touted "the most sweeping action in history to lower the price of prescription drugs for the American people," in a focused speech. Trump pledged "tougher negotiation, more competition and much lower prices at the pharmacy counter," as well as an elimination of middlemen, who he said "won't be so rich anymore."
Eli Lilly and Co. said it will buy Armo Biosciences Inc. for about $1.6 billion, in an all-cash transaction intended to bolster its immuno-oncology program through the addition of Armo's lead candidate, pegilodecakin, a pegylated interleukin-10. The $50-per-share offer, coming just months after Armo's upsized January IPO, represents a 68 percent premium to Wednesday's close.
Bioclin Therapeutics Inc., a startup developing a monoclonal antibody (MAb) to fight metastatic bladder cancer, has expanded its series B financing to $50 million. Proceeds from the round will be used to support phase II testing of the company's lead candidate, B-701, both as a single agent as well as in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) and separately with docetaxel. Enrollment in phase II trials of the anti-fibroblast growth factor receptor-3 (FGFR3) MAb is expected to wrap up by the second half of 2018, with initial data expected by year-end, said Stephen Lau, CEO of the San Leandro, Calif.-based venture.
Fresh off presenting positive new mechanistic data on its lead candidate, seladelpar, at the 2018 International Liver Congress in Paris, Cymabay Therapeutics Inc. said patient screening for a phase IIb proof-of-concept study of the drug in nonalcoholic steatohepatitis (NASH) is now underway. Enrollment is estimated to take about 12 months, with a top-line readout expected in the second half of 2019, Cymabay's CEO and president, Sujal Shah, told BioWorld.
Cortexyme Inc., a stealthy South San Francisco-based biotech exploring developing therapies for Alzheimer's disease (AD) and other degenerative disorders, is moving ahead with development of a bacterial protease inhibitor. The candidate, COR-388, targets a pathogen identified in the brain tissue and cerebral spinal fluid of patients with AD. It started the first of two phase I studies in January. Both trials, a single ascending dose and a multiple ascending dose in healthy elderly participants, will finish by May. Meanwhile, it's moving toward publication of a manuscript detailing its approach.
Arrevus Inc., a privately-held Raleigh, N.C.-based biotech designing proline-rich antimicrobial peptides for the treatment of infectious disease, has received a $1.5 million fast-track grant from the National Institute of Allergy and Infectious Diseases (NIAID) to expedite research on the effects of its lead candidate, ARV-1502, on bacteremia caused by multi-drug resistant pathogens. The award follows the closing of a $1.3 million series A financing from Tokyo-based MBL Venture Capital Co. Ltd. late last year that has helped the company accelerate its progress.
Refuge Biotechnologies Inc., a company developing chimeric antigen receptor (CAR) T-cell therapies designed to enable multitargeted cancer treatment, has raised a $25 million series B round. The new funds will support advancement of multiple CRISPR-leveraging candidates, including the company's lead, the preclinical CAR RB-1916 for diffuse large B-cell lymphoma.
Directors at Ironwood Pharmaceuticals Inc. have green-lit plans to spin off the company's R&D programs into a new publicly traded company, a move that could help sales of Linzess (linaclotide) and other approved treatments carry the commercial business to profitability in 2019 while compartmentalizing risks of its rare disease-focused soluble guanylate cyclase (sGC) stimulator programs.
